Overview
Sponsor-declared trial summary
Capecitabine-induced hand and foot syndrome
Safety of TAR-0520 Gel in colorectal or breast cancer patients treated with capecitabine.
Key facts
- Sponsor
- Tarian Pharma
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Decision date (initial)
- 2026-02-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
- Funding sources
- TARIAN Pharma
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis, Safety
Safety of TAR-0520 Gel in colorectal or breast cancer patients treated with capecitabine.
Secondary objectives 1
- Explore the preventative effect of TAR-0520 Gel on capecitabine-induced HFS in colorectal or breast cancer patient
Conditions and MedDRA coding
Capecitabine-induced hand and foot syndrome
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10048776 | Hand and foot syndrome secondary to chemotherapy | 10040785 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Male or female, who is at least 18 years of age or older at screening visit
- Medical diagnosis of breast or colorectal cancer planned to be treated with capecitabine monotherapy, either in adjuvant/neoadjuvant or palliative setting
- Starting capecitabine at a dose ≥ 1000 mg/ m² twice daily every 2 out of 3 weeks as single-agent chemotherapy
Exclusion criteria 3
- Patient with a medical history of capecitabine treatment
- Patient with pre-existing grade 2 or higher neuropathy confounding assessment of HFS
- Patient with Raynaud’s syndrome or other vascular peripheral disorders
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Incidence of Adverse Events, Adverse Events of Special Interest and Serious Adverse Events
Secondary endpoints 1
- Incidence and severity of NCI-CTCAE (Palmar-plantar erythrodysesthesia syndrome) grading by oncologist
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11643666 · Product
- Active substance
- Brimonidine Tartrate
- Pharmaceutical form
- GEL
- Route of administration
- TOPICAL USE
- Max daily dose
- 3.2 g gram(s)
- Max total dose
- 128 g gram(s)
- Max treatment duration
- 40 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- TARIAN PHARMA
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Tarian Pharma
- Sponsor organisation
- Tarian Pharma
- Address
- 4 Traverse Dupont
- City
- Grasse
- Postcode
- 06130
- Country
- France
Scientific contact point
- Organisation
- Tarian Pharma
- Contact name
- Janusz Czernielewski
Public contact point
- Organisation
- Tarian Pharma
- Contact name
- Janusz Czernielewski
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 25 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 13 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-524008-32-00 | 2.0 |
| Protocol (for publication) | D1_Protocol 2025-524008-32-00_TC | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_EN | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_Patient card | 2.0 |
| Subject information and informed consent form (for publication) | L1_Patient card_TC | 2.0 |
| Subject information and informed consent form (for publication) | L1_Patient instructions_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_FR | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_FR_TC | 2.0 |
| Subject information and informed consent form (for publication) | L1_Subject Diary | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis EN 2025-524008-32-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis FR 2025-524008-32-00 | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis FR TC 2025-524008-32-00 | 3 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-07 | France | Acceptable 2026-02-05
|
2026-02-16 |